Description

Miconazole Impurity H is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of miconazole-based antifungal drug products. It is primarily utilized by research scientists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical and biotechnology industries for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in miconazole API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and GC analytical methods.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research and Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	Miconazole Impurity H
CAS No.	181931-30-6
Molecular Formula	C18H14Cl4N2O
Molecular Weight	416.13 g/mol
Synonyms	1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole; Miconazole EP Impurity H; Miconazole Related Compound H; (RS)-1-(2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy]phenethyl)imidazole; Miconazole Impurity 8; UNII-2K6U6SXM5T
EINECS	Contact for details

Quality Control

Our Miconazole Impurity H is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures the material is suitable for GMP-regulated pharmaceutical analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.